JOURNEY IIRecalls & reported problems across all models
Smith & Nephew, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 22 models of JOURNEY II by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2019 and Apr 20, 2026 — classified as 22 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported JOURNEY II problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Fracture7
- Loosening of Implant Not Related to Bone-Ingrowth4
- Break3
- Crack3
- Incomplete or Inadequate Connection2
- Insufficient Device Problem Information2
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Pain9
- Failure of Implant6
- Inadequate Osseointegration4
- Injury3
- Bone Fracture(s)2
- Metal Related Pathology2
- Synovitis2
JOURNEY II models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- JOURNEY II 71935194PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- JOURNEY II 71935200PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- JOURNEY II 71935205PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- JOURNEY II 71935104PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY II 71935201PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY II 71935100PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II 71935195PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II 71935198PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II 71935212PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II 71935214PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II 71935221PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II 71935225PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Journey II 71935481PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Journey II E0016196-3PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Journey II E0016299-4PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Journey II E0016299-7PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II 74014542PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II 74033835TEMPLATE1 report
- JOURNEY II 74033841TEMPLATE1 report
- JOURNEY II 74033844TEMPLATE1 report
- JOURNEY II 74033855TEMPLATE1 report
- Journey II E0017011-1PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent JOURNEY II adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA, WHEN THE SURGEON WAS PLACING A JII BCS INSERT TRIAL 1-2 10MM RIGHT ON THE BASE PLATE, IT CHIPPED OFF. ADDITIONALLY, ONE OF THE RIVETS OF A JRN II BCS BOX PREP GD SZ3-5 CAME DISSOCIATED FROM THE HINGE. ALL PIECES WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933556 ↗MalfunctionMay 15, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JII BCS INSERT TRIAL 5-6 9MM LEFT FRACTURED INTO TWO PIECES WHILE TRIALING THE KNEE. ALL PIECES RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024919 ↗MalfunctionJul 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE JII CR INSERT TRIAL SZ 5-6 9MM LEFT BROKE IN HALF. ALL FOUR PIECES WERE RECOVERED FROM THE PATIENT WITH AN UNKNOWN METHOD. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19772005 ↗MalfunctionMay 6, 2024Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY, THE NARROW CAPTURELESS JII AP BLOCK SZ 8 BROKE OFF WHILE THE BLOCK WAS ON THE KNEE. THE PIECE THAT BROKE OFF WAS GRABBED AND THROWN AWAY. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH A S+N BACK-UP DEVICE. NO INJURIES TO THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19248872 ↗InjuryFeb 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, A PRIMARY TKA WAS PERFORMED ON (B)(6) 2017, THE PATIENT WAS THEN INVOLVED IN A CAR ACCIDENT, WHICH MAY HAVE CAUSED THE JII UNI TIB XLPE INS SZ 5-6 9MM LM/RL TO FAIL. TO TREAT THIS EVENT A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2024. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. FURTHER INFORMATION HAS NOT BEEN MADE AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 18670549 ↗MalfunctionMay 3, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE JII BCS INSERT TRIAL 5-6 9MM RIGHT SNAPPED IN HALF WHILE IN USE INSIDE THE PATIENT. IRRIGATION WAS USED TO CLEAN THE WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16860888 ↗InjuryApr 19, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN DUE TO A PREMATURE POLYETHYLENE WEAR FOLLOWING IMPLANTATION OF PROSTHESIS MEDIAL MONOCOMPARTIMENTAL RIGHT KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A JII UNI TIB XLPE INS SZ 5-6 8MM RM/LL WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Pain
MAUDE report 16771347 ↗MalfunctionMar 7, 2023Flaked; Flaked
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TAP OF THE NARROW CAPTURELESS JII AP BLOCK SZ-5 DEVICE WHERE THE SLAP HAMMER ATTACHES CHIPPED OFF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16496217 ↗MalfunctionFeb 8, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE TAB OF A NARROW CAPTURELESS JII AP BLOCK SZ-8 (THAT IS USED FOR THE SLAP HAMMER TO GO OVER) BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16325547 ↗InjuryDec 12, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. A REVISION SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE TO TREAT THIS ADVERSE COMPLICATION. DURING THIS PROCEDURE, ALL COMPONENTS WERE REVISED AS THE KNEE WAS CONVERTED TO A TKA. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED SEVEN (7) MONTHS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 15965511 ↗InjuryDec 12, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. A REVISION SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE TO TREAT THIS ADVERSE COMPLICATION. DURING THIS PROCEDURE, THE TIBIAL BASE PLATE WAS EXPLANTED AND REPLACED WITH ANOTHER SMITH AND NEPHEW IMPLANT. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED AT ALMOST NINE (9) MONTHS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 15965092 ↗InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN ACUTE INSUFFICIENCY FRACTURE UNDER THE LEFT MEDIAL PLATEAU AFTER A PAINFUL PHYSIOTHERAPY SESSION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE COMPLICATION. DURING THIS PROCEDURE, ALL COMPONENTS WERE REVISED AS THE KNEE WAS CONVERTED TO A TKA. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED 0.5 MONTHS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 15964208 ↗InjuryDec 1, 2022Migration; Migration
IT WAS REPORTED THAT, AFTER A UKR SURGERY WAS PERFORMED ON (B)(6) 2022, PATIENT EXPERIENCED MEDIAL KNEE PAIN ASSOCIATED WITH TIBIAL COMPONENT SUBSIDENCE. THIS ADVERSE EVENT WAS IDENTIFY BY A CLINICAL STUDY ON (B)(6) 2022. A REVISION SURGERY HAS BEEN PLANNED. PATIENT'S CURRENT HEALTH STATUS IS ONGOING.
Patient problems: Pain
MAUDE report 15895872 ↗InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2019, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020. THE CAUSE OF THE REVISION SURGERY IS UNSPECIFIED. THE PATIENT HAS RECOVERED FROM REVISION SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 12924358 ↗InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2019, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020. THE CAUSE OF THE REVISION SURGERY IS UNSPECIFIED. THE PATIENT HAS RECOVERED FROM REVISION SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 12924266 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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